Model Number 350P |
Device Problem
Failure to Deliver Shock/Stimulation (1133)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/03/2022 |
Event Type
malfunction
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Event Description
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The distributor contacted heartsine to report that their device does not give a shock during testing.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
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Manufacturer Narrative
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Heartsine technologies ltd has requested the return of the device from the distributor in order to investigate the alleged malfunction.Upon completion, the conclusions will be submitted in a follow-up report.
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Event Description
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The distributor contacted heartsine to report that their device does not give a shock during testing.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
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Manufacturer Narrative
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Heartsine's investigation of the device confirmed the reported fault as upon return the device was unable to deliver a shock.The reported fault was attributed to a failed capacitor, which forms part of the switching circuitry used to deliver phase one of shock delivery.The device was scrapped by heartsine and the customer was provided with a replacement device.D2 update: due to new fda approval for this model, the product code has been updated from mkj to nsa.
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Search Alerts/Recalls
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